The INVADE Study: INnominate Vein Approach for Central Catheterization in Difficult to cannulatE Patients

Critical Illness Clinical Trial

— INVADE  

Official title:

Central Venous Access in Patients With Difficult Cannulation, A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04265703
• Other study ID #: HCG/CEI-1196/19
• Status: Recruiting
• Phase: N/A
• Start date: October 12, 2019
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: Hospital Civil de Guadalajara
• Contact: Miguel Ibarra-Estrada, MD
• Phone: 3317593502
• Email: drmiguelibarra[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Most recent guidelines suggest central venous access must be performed with real-time ultrasound guidance, and the most recommended site for cannulation is internal jugular vein (IJV); however, it is recognized that evidence for other sites is, at present, limited. Besides, guidelines does not account for patients with small vein cross-sectional area and/or respirophasic collapse, which can make the procedure more difficult or even impossible. The investigators aim to compare three different insertion sites for central venous access, with real-time ultrasound guidance

Description:

Ultrasound-guided cannulation of central veins is successful in >95% of the cases, according to the largest study so far. However, this and other studies with similar success rate, are performed in patients with general anesthesia and/or neuromuscular blockade, without spontaneous respiratory efforts. Critical care physicians and many other specialists frequently need to cannulate patients in special circumstances as hypovolemia, pain, anxiety, and respiratory efforts that promotes respirophasic variation in cross-sectional area, and even complete collapse of the vessel. These changes can increase the probability of posterior wall or arterial puncture, hematomas, pneumothorax, etc. Supraclavicular approach for cannulation of the subclavian vein is a method described since 1965, also giving direct access to the innominate vein, a larger vessel which is rarely collapsible regardless of volume status or respiratory efforts. Based on a previous pilot trial, in this multi-center, prospective, randomized, controlled trial, the investigators aim to compare the successfulness and safety of ultrasound-guided central venous cannulation at 3 different sites: internal jugular, subclavian, and innominate veins.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients who need central venous catheterization, and have respirophasic variation in cross-sectional area of jugular veins

Exclusion Criteria:

• Less than 18 years-old

• Patients with previous failed attempts with non-ultrasound guided technique

• Non-resolved pneumothorax/hemothorax at enrollment

• Refusal to sign informed consent

Related Conditions & MeSH terms

• Critical Illness

Intervention

Procedure:
• Internal jugular vein catheterization
Catheterization of internal jugular vein with real-time (in-plane) method, with neutral neck position. Standard aseptic technique.
• Subclavian vein catheterization
Catheterization of subclavian/axillary vein with infra-clavicular approach with real-time (in-plane) method, without shoulder retraction. Standard aseptic technique.
• Innominate vein catheterization
Catheterization of innominate vein with supra-clavicular approach with real-time (in-plane) method, with neutral shoulder position and no shoulder retraction. Standard aseptic technique.

Locations

Country	Name	City	State
Mexico	Hospital Civil Fray Antonio Alcalde	Guadalajara

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Civil de Guadalajara	Instituto Jalisciense de Cancerologia

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cannulation failure rate	Failure to cannulate selected vein at first attempt	Baseline
Secondary	Central line-associated blood infection rate	Confirmed with blood cultures	28 days
Secondary	Collapsibility associated with failure	Percentage of vein collapsibility independently associated with cannulation failure	Baseline
Secondary	Cannulation number of attempts	Number of attempts needed to attain cannulation	Baseline
Secondary	Procedure time	Time from skin puncture to guidewire confirmed into vessel (minutes)	Baseline
Secondary	Arterial puncture rate	Confirmed immediately after procedure with vascular ultrasound	Baseline
Secondary	Hematoma formation rate	Confirmed immediately after procedure with vascular ultrasound	7 days
Secondary	Neumothorax rate	Confirmed immediately after procedure with lung ultrasound	7 days
Secondary	Hemothorax rate	Confirmed immediately after procedure with lung ultrasound	7 days